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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Alinity c IgE Reagent Kit — 2 UDI-DI variants, IVDR (Biokit S.A.)

MD Atlas
Biokit S.A.

Data from EUDAMED, last updated May 23, 2026

Alinity c IgE Reagent Kit

8436003070405X6

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class B

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Manufacturer: Biokit S.A.

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Device characteristics

ReagentProfessional testingAnimal tissues / cells

Identity & classification

Basic UDI-DI: 8436003070405X6
Device name: Alinity c IgE Reagent Kit
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class B
Version date: Oct 8, 2025

Manufacturer & authorised representative

Manufacturer

Name: Biokit S.A.
SRN: ES-MF-000002406
Country: Spain
Email: oem-biokit@werfen.com
Phone: +34 938609000

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01K71K7RMXTRBD10GQV2404E6D

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

01R132208436003070405
01R130108436003070412